Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-26 @ 9:34 PM
Study NCT ID:
NCT05281692
Status:
COMPLETED
Last Update Posted:
2022-10-18
First Post:
2022-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of EPM-IX to Currently Used Specimen Transportation and Extraction Devices ( CGI-EPM-IX )
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'EPM-IX is a clinical specimen collection medium that inactivates pathogens, preserves nucleic acids, and integrates DNA/RNA purification. EPM-IX eliminates the need for additional extraction reagents or kits and purifies DNA/RNA from the entire sample to enable optimal test performance.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-14', 'studyFirstSubmitDate': '2022-03-07', 'studyFirstSubmitQcDate': '2022-03-07', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Diagnostic Performance', 'timeFrame': 'At the time of inclusion', 'description': "Comparison of diagnostic performances (sensitivity, specificity, and predictive values) of EPM-IX vs Med Schenker's STM viral media with detection of SARS-CoV-2 infection."}], 'secondaryOutcomes': [{'measure': 'Comparison of Lab Processing', 'timeFrame': 'At the time of inclusion', 'description': "Comparison of Lab processing time with accessioning and processing of an EPM-IX tube compared to with Med Schenker's STM viral media"}, {'measure': 'Quantitative PCR CT-values', 'timeFrame': 'At the time of inclusion', 'description': "Quantitative PCR CT-values (of internal control and target gene levels) using EPM-IX vs Med Schenker's STM viral media"}, {'measure': 'Difference in case rate or detection of viral load samples observed', 'timeFrame': 'At the time of inclusion', 'description': "Difference in case rate or detection of viral load samples observed between EPM-IX and Med Schenker's STM viral media"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EPM-IX', 'Covid-19', 'SARS-CoV-2', 'Nasopharyngeal swab', "Med Schenker's STM viral media"], 'conditions': ['SARS-CoV-2']}, 'descriptionModule': {'briefSummary': 'This is a research study to evaluate the clinical utility of the Enhanced Preservation Media with Integrated Extraction (EPM-IX)', 'detailedDescription': "This is a minimal risk study where patients at UroPartners Urology Group will consent to SARS-CoV-2 nasopharyngeal swab testing using both, a standard of care test with standard Viral Transport Medium and a second test using Convergent Genomics' proprietary Enhanced Preservation Media (EPM-IX). Subjects will self-swab each nostril during their medical appointment at UroPartners. UroPartners designated staff with then send the collection kits out for testing. Clinical information will be collected that includes age, gender, race, ethnicity and history of cancer. All of these data points will be anonymized."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female subjects ≥ 18 years of age who are being tested for COVID-19', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be ≥18 years of age\n* Subject is a current patient at UroPartners and is willing to be tested for Covid- 19 during a routine visit\n* Subject must be able to understand and willingly provide informed consent\n\nExclusion Criteria:\n\n* Cannot provide informed consent'}, 'identificationModule': {'nctId': 'NCT05281692', 'acronym': 'CGI-EPM-IX', 'briefTitle': 'Comparison of EPM-IX to Currently Used Specimen Transportation and Extraction Devices ( CGI-EPM-IX )', 'organization': {'class': 'NETWORK', 'fullName': 'Convergent Genomics, Inc.'}, 'officialTitle': 'Prospective, Non-Randomized, Parallel Assignment and Single Site Comparison of EPM-IX to Currently Used Specimen Transportation and Extraction Devices', 'orgStudyIdInfo': {'id': 'CGI-EPM-IX'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Positive', 'description': 'Enhanced Preservation Media (EPM-IX)', 'interventionNames': ['Diagnostic Test: Enhanced Preservation Media (EPM-IX)']}, {'label': 'Control', 'description': "Med Schenker's STM viral media", 'interventionNames': ['Diagnostic Test: Enhanced Preservation Media (EPM-IX)']}], 'interventions': [{'name': 'Enhanced Preservation Media (EPM-IX)', 'type': 'DIAGNOSTIC_TEST', 'description': 'EPM-IX is a clinical specimen collection medium that inactivates pathogens, preserves nucleic acids, and integrates DNA/RNA purification. EPM-IX eliminates the need for additional extraction reagents or kits and purifies DNA/ RNA from the entire sample to enable optimal test performance.', 'armGroupLabels': ['Control', 'Positive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'UroPartners Urology Group', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Paul Yonover, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UroPartners, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Convergent Genomics, Inc.', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}